Comparison of Image Quality Between "Double Low Dose" Liver CT and Standard Liver CT
1 other identifier
interventional
176
1 country
1
Brief Summary
In patients with malignancies, contrast-enhanced abdominal CT (hereafter abdominal CT) plays an important role in detecting carcinoma recurrence and assessing treatment response. In this study, we aim to investigate whether such a "double low" dose CT is feasible in patients with liver metastases of colorectal cancer using a vendor-agnostic artificial intelligence-based noise reduction and contrast enhancement software.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2023
CompletedFirst Posted
Study publicly available on registry
March 30, 2023
CompletedStudy Start
First participant enrolled
May 30, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2025
CompletedJune 5, 2023
June 1, 2023
1.6 years
March 17, 2023
June 1, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
lesion conspicuity on portal venous phase
qualitative analysis of lesion conspicuity on portal venous phase on five-point scale (higher score indicates better conspicuity). Lesion conspicuity is compared between the two arms.
6 months after primary study completion.
Secondary Outcomes (4)
lesion conspicuity on arterial phase
6 months after primary study completion.
lesion detectability
12 months after primary study completion.
Radiation dose
1 month after primary study completion
Contrast media (CM) dose
1 month after primary study completion
Study Arms (2)
Standard dose CT
ACTIVE COMPARATORStandard dose protocol CT using standard radiation dose (120 kVp) and standard dose of contrast media, and reconstructed with commercially available reconstruction algorithm of the CT scanner.
Double low dose CT
EXPERIMENTALDouble low dose protocol CT using low radiation dose (120 kVp \& 70% of reference mAs of standard dose CT) and low dose of contrast media, and reconstructed with commercially available vendor-agonistic AI-based software.
Interventions
Simultaneous reduction of both radiation dose and contrast media dose
CT with standard radiation dose and contrast media dose
Eligibility Criteria
You may qualify if:
- colorectal cancer (CRC) patients
- on surveillance or monitoring for liver metastasis (of CRC)
You may not qualify if:
- any relative or absolute contra-indication of CECT
- diffuse infiltrative type of liver metastasis or on monitoring for too many liver lesions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Seoul National University Hospitallead
- Bayercollaborator
Study Sites (1)
Seoul National University Hospital
Seoul, 03080, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jeong Min Lee, MD
Seoul National University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
March 17, 2023
First Posted
March 30, 2023
Study Start
May 30, 2023
Primary Completion
December 31, 2024
Study Completion
June 30, 2025
Last Updated
June 5, 2023
Record last verified: 2023-06
Data Sharing
- IPD Sharing
- Will not share